Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Summary

The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.

Conditions

• Bronchopulmonary Dysplasia
• Child Development
• Neonatal and Perinatal Conditions

Interventions

DIETARY_SUPPLEMENT

DHA-rich algal oil

Mothers will receive a DHA-rich algal oil treatment (400 mg DHA per capsule) three times a day before meals from randomization (\<72 hours post-delivery) until the infant reaches 36 weeks PMA.

COMBINATION_PRODUCT

Placebo

Mothers will receive a placebo capsule three times a day before meals from randomization (\<72 hours post-delivery) until the infant reaches 36 weeks PMA.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Laval University

  collaborator OTHER

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Isabelle Marc, MD, PhD · CHU de Québec, Université Laval

• Pascal Lavoie, MD, PhD · Children's and Women's Health Centre of BC, University of British Columbia

• Benoît Mâsse, PhD · CHU Sainte-Justine, Université de Montreal

• Thierry Lacaze, MD, PhD · Children's Hospital of Eastern Ontario, University of Ottawa

• Anne-Monique Nuyt, MD, PhD · CHU Sainte-Justine, Université de Montreal

• William Fraser, MD, MSc · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-23

Primary Completion

2019-04-25

Completion

2026-03-31

Countries

• Canada

Study Locations